Tuesday, May 08, 2007

FDA Guidance for Industry on CAM

I apologize for not posting this sooner. T-from-F sent this to me last week, but I got so caught up in bad-food-anger, and then immersed in the tedium of a 94-page piece of fix-the-bad-food legislation that I let it slide.

While I was letting it slide the FDA comment period for it passed ... maybe.

Here's the site T-from-F sent:FDA Regulators Using Legal Trickery to Jeopardize Alternative Procedures and Products

Unfortunately, the site and its message are more about an anti-government group crying wolf than about reasoned thinkers distributing level-headed advice. Just because something is hosted by the democracyinaction.org site doesn't mean it's sensible. In this case, I think it's unduly inciting and meant to scare.

As you can see, it culminates with a pre-completed comment form, compliments of the Natural Solutions Foundation, to the FDA, insinuating that the FDA is trying to squelch "health freedoms".

I wonder if people who are signing this have read the words in the box, and if they truly endorse their message. It's long (about 2000 words), meandering, and full of curious, unsubstantiated phrases:

"Many health problems [are] caused by government intervention."

"[Regulated prescription] drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide."

"Invasive techniques and toxic drugs are the sole provenance of licensed medicine."

The author, Albert N. Stubblebine, offered no clinical or epidemiological backup for his broad and biased claims. That substantiation may be hard to come by though, since CAM remedies are not studied as rigorously as conventional (allopathic) remedies for efficacy or side effects, so data on their impact to populations is sparse.

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Background

On February 27, 2007, the FDA posted a document-in-progress called a "Draft Guidance", directed at "industry" and intended to clarify how the FDA regulates products and therapies that fall under the heading of "Complementary and Alternative Medicine", CAM for short.

Here's their draft document:Docket No. 2006D-0480:Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

Here's a summary:Draft Guidance for Industry on CAM Products and Their Regulation by the FDA

I read it and found it did nothing more than provide definitions and clarify which products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, and which fall under the Public Health Service Act. Nothing new here.

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Pandemonium Ensued

After it was posted, the internet burned with conspiracy theories, many spawned by T-from-F's site and their supporters. Fears were generated that the FDA, via this Draft Guidance, was out to shut down chiropractors and confiscate cranberry juice and holy water.

One conspiracy theorist, Mike Adams at NewsTarget.com, says that the FDA's document may cause the following things to occur:

Growing and selling common garden herbs will get you arrested as a drug dealer.

Yoga props will be regulated as "medical devices" and require FDA approval before being sold or used.

Bottled water that "treats" dehydration will be regulated as a drug.

Green tea will be outlawed and confiscated.

Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.

These are not true. This Guidance Document clarifies present law. It does not change law, only Congress can do that. In fact, if you are concerned about the direction the FDA is taking regarding CAM, it would be more effective to write to Congress, not the FDA. Congress created the FDA; Congress finances the FDA; Congress directs the FDA.

Below is an interview with Philip Chao, a senior scientific advisor at the FDA and one of the authors of the FDA document. In it, he says the FDA document:

Does not change any law. (Only Congress can do that.)

Does not "turn supplements into drugs". (Drugs undergo more stringent regulation.)

"Activism" as promulgated by groups such as the Natural Solutions Foundation (who sell vitamins, supplements, and other healthcare products on their site) is unfortunate. It revs up the hearts and minds of a limited (and necessary) group of well-meaning, health-minded enthusiasts. It then exploits their energy for selfish purposes. Also, in mobilizing their (our) power to achieve their ends, it distracts from more important issues regarding supplements and other CAM products.

I'll be back with more soon. (Okay, here's more.)

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Illustration of materia medica from ibiblio.orgThe illustration (rose) is from a picture book, the Circa instans, thought to be produced at the medical school of Salerno, Italy in the mid-twelfth century. It depicts natural, medicinal remedies from Latin and Arabic sources.